NCT03182842

FreeStyle Libre FGM During Summer Camp for Children With Type 1 Diabetes

Completed NA Last updated 5 July 2017

What this trial tests

NA trial testing FreeStyle Libre FGM in Type 1 Diabetes Mellitus in 45 participants. Completed in 1 July 2017.

Timeline

17 June 2017

Primary endpoint
1 July 2017

1 July 2017

Quick facts

Lead sponsor	University of Ljubljana, Faculty of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	17 June 2017
Primary completion	1 July 2017
Estimated completion	1 July 2017
Sites	1 location across Slovenia

Drugs / interventions tested

• FreeStyle Libre FGM
• SMBG - Blinded Sensor

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
• Hypoglycemia — all drugs for Hypoglycemia →
• Hyperglycemia — all drugs for Hyperglycemia →

Sponsor

University of Ljubljana, Faculty of Medicine

Who can join

Adults 6 to 15, any sex, with Type 1 Diabetes Mellitus or Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle Libre Flash Glucose Monitoring System (FGM - intervention, Abbott Diabetes Care, California, USA) versus Self-Monitoring Blood Glucose (SMBG - control).

Study duration will be two weeks per subject and two weeks overall, it will take place at youth summer camp for children with T1D. Main inclusion criteria include age of six to 15 (inclusive) years, clinical diagnosis of T1D for at least six months, at least three months of current use of insulin pump therapy, HbA1c between 6.3 and 10 % (both inclusive), no other chronic medical conditions (beside treated hypothyroidism and celiac disease) and no current medications (other than insulin) (detailed list of inclusion and exclusion criteria list can be found at section 6).

The objectives of this clinical investigation is:

1\. to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with T1D during two weeks of summer camp.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Non-adjunctive flash glucose monitoring system use during summer-camp in children with type 1 diabetes: The free-summer study.
   Piona C, Dovc K, Mutlu GY, Grad K, et al · · 2018 · cited 23× · PMID 30022571 · DOI 10.1111/pedi.12729
2. Flash Glucose Monitoring System for People with Type 1 or Type 2 Diabetes: A Health Technology Assessment.
   Ontario Health (Quality) . · · 2019 · cited 6× · PMID 31942227